Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs

The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: Newly developed warnings with images at 30% size; Behavioral: FDA proposed text-only warnings at 30% size

Detailed Description

In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study. To collect at least 750 quality completes the investigators anticipate enrolling up to 3,000 people.

At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol.

For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions.

On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts.

For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O

• Study Type: Interventional
• Enrollment (Actual): 1029
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam O Goldstein, MD, MPH; Phone Number: 984-974-4647; Email: adam_goldstein@med.unc.edu
• Study Contact Backup: Name: Kristen L Jarman, MSPH; Phone Number: 919-966-3016; Email: jkristen@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Members of the recruitment panel (the investigators are partnering with a panel provider for recruitment of all participants)
• Agree to provide their honest answers
• Current little cigar and/or cigarillo every day or some day users
• Over 21 years old
• Currently living in US
• Feel comfortable taking a survey in English without help
• Feel comfortable taking an online survey without help
• Have an email address that they check regularly
• Have access to the internet at work or home
• Able to read and respond to surveys delivered to their email
• Able to complete 2 surveys that take approximately 20 minutes
• Able to complete a 5 minute survey each day for 20 days
• Able to verify they are not a bot using CAPTCHA
• Able to answer a simple, random math question

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newly developed warnings with images; Participants receive newly developed warnings intervention	Behavioral: Newly developed warnings with images at 30% size; On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.
Experimental: FDA proposed text-only warnings; Participants receive FDA proposed text only warning intervention	Behavioral: FDA proposed text-only warnings at 30% size; On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.
No Intervention: Control group, no intervention; Participants do not receive an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LCC quit intentions	Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.	day 21 (post test)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of LCCs smoked in past day	Measured by survey	day 1
Number of LCCs smoked in past day	Measured by survey	day 2
Number of LCCs smoked in past day	Measured by survey	day 3
Number of LCCs smoked in past day	Measured by survey	day 4
Number of LCCs smoked in past day	Measured by survey	day 5
Number of LCCs smoked in past day	Measured by survey	day 6
Number of LCCs smoked in past day	Measured by survey	day 7
Number of LCCs smoked in past day	Measured by survey	day 8
Number of LCCs smoked in past day	Measured by survey	day 9
Number of LCCs smoked in past day	Measured by survey	day 10
Number of LCCs smoked in past day	Measured by survey	day 11
Number of LCCs smoked in past day	Measured by survey	day 12
Number of LCCs smoked in past day	Measured by survey	day 13
Number of LCCs smoked in past day	Measured by survey	day 14
Number of LCCs smoked in past day	Measured by survey	day 15
Number of LCCs smoked in past day	Measured by survey	day 16
Number of LCCs smoked in past day	Measured by survey	day 17
Number of LCCs smoked in past day	Measured by survey	day 18
Number of LCCs smoked in past day	Measured by survey	day 19
Number of LCCs smoked in past day	Measured by survey	day 20
Number of LCCs smoked in past day	Measured by survey	day 21 (post test)
Number of days smoked LCCs in past week	Measured by survey	day 7
Number of days smoked LCCs in past week	Measured by survey	day 14
Number of days smoked LCCs in past week	Measured by survey	day 21 (post test)
Number of LCCs smoked in the past week	Measured by survey	day 7
Number of LCCs smoked in the past week	Measured by survey	day 14
Number of LCCs smoked in the past week	Measured by survey	day 21 (post test)
Number of LCCs butted out in the past week	Measured by survey	day 7
Number of LCCs butted out in the past week	Measured by survey	day 14
Number of LCCs butted out in the past week	Measured by survey	day 21 (post test)
Number of LCCs forgone in the past week	Measured by survey	day 7
Number of LCCs forgone in the past week	Measured by survey	day 14
Number of LCCs forgone in the past week	Measured by survey	day 21 (post test)
LCC quit attempts in past week	Measured by survey	day 7
LCC quit attempts in past week	Measured by survey	day 14
LCC quit attempts in past week	Measured by survey	day 21 (post test)
LCC quit intentions	Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.	day 7
LCC quit intentions	Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.	day 14
Self reported learning	Measured by survey. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings.	day 21 (post test)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Adam O Goldstein, the University of North Carolina (UNC) Department of Family Medicine

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): August 27, 2023
• Study Completion (Actual): August 27, 2023

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cigar Warnings; Little Cigar Use; Cigar Use; Cigarillo Use
• Other Study ID Numbers: 22-2531; R01CA240732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will make data collection instruments available for public use after data collection and analyses are complete. On request, the investigators will also make data sets available, stripped of individual identifiers, following publication of the study's main findings.
• IPD Sharing Time Frame: The supporting documents and data will become available when study results are submitted to ClinicalTrials.gov. Deidentified study data sets will be available, by request, following publication of the study's main findings.
• IPD Sharing Access Criteria: The investigators will decide whether to share deidentified study data sets on a case by case basis, and will prioritize sharing the data sets with qualified tobacco regulatory science researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No